Oxytocin versus prostaglandins for labour Induction of women with an unfavourable cervix after 24 hours of cervical ripening (OPIC): protocol for an open multicentre randomised non-inferiority trial

Introduction
It remains uncertain whether the most appropriate management for women with an unfavourable cervix after 24 hours of cervical ripening is repeating the ripening procedure or proceeding directly to induction by oxytocin. No adequately powered trial has compared these strategies. We hypothesise that induction of labour with oxytocin among women who have just undergone an ineffective first ripening procedure is not associated with a higher risk of caesarean delivery than a repeated cervical ripening with prostaglandins.

Methods and analysis
We will conduct a multicentre, non-inferiority, open-label, randomised controlled trial aimed at comparing labour induction by oxytocin with a second cervical ripening that uses prostaglandins (slow-release vaginal dinoprostone; oral misoprostol 25 µg; dinoprostone vaginal gel 2 mg). Women (n=1494) randomised in a 1:1 ratio in 10 French maternity units must be ≥18 years with a singleton fetus in vertex presentation, at a term from ≥37+0 weeks of gestation, and have just completed a 24-hour cervical ripening procedure by any method (pharmacological or mechanical) with a Bishop score ≤6. Exclusion criteria comprise being in labour, having more than 3 contractions per 10 min, or a prior caesarean delivery or a history of uterine surgery, or a fetus with antenatally suspected severe congenital abnormalities or a non-reassuring fetal heart rate. The primary endpoint will be the caesarean delivery rate, regardless of indication. Secondary outcomes concern delivery, perinatal morbidity, maternal satisfaction and health economic evaluations. The nature of the assessed procedures prevents masking the study investigators and patients to group assignment.

Ethics and dissemination
All participants will provide written informed consent. The ethics committee ‘Comité de Protection des Personnes Ile de France VII’ approved this study on 2 April 2021 (No 2021-000989-15). Study findings will be submitted for publication and presented at relevant conferences.

Trial registration number
NCT04949633.

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Aprile 2023

Abstract WP106: Hemispheric Comparison Of Magnetic Susceptibility 24-72 Hours After Reperfusion

Stroke, Volume 54, Issue Suppl_1, Page AWP106-AWP106, February 1, 2023. Introduction:Magnetic susceptibility is a radiological contrast mechanism that may provide a measure of oxygenation and contribute to an understanding the pathophysiology of stroke. Currently, there are few studies that have explored magnetic susceptibility in ischemic tissue as a marker of tissue injury. Our study assesses day one ischemic tissue post-reperfusion for changes in magnetic susceptibility and evaluates its relationship with radiological markers of ischemic injury – apparent diffusion coefficient (ADC).Methods:In a prospective observational study, thirty-five ischemic stroke patients who underwent endovascular thrombectomy were scanned with MRI (24 – 72 hours after reperfusion) to obtain multi-echo Gradient Echo and DWI images. An experienced neuroradiologist manually delineated ischemic tissue ROIs (region of interest) on DWI images. Contralateral ROIs were obtained using an automated method. The cerebrospinal fluid and regions of haemorrhagic transformation were excluded from the ROIs. A Morphology Enabled Dipole Inversion (MEDI) pipeline was employed to generate Quantitative Susceptibility Mapping (QSM) images, and these were used to quantify magnetic susceptibility. Mean magnetic susceptibility and mean ADC values were measured in these ROIs, and these values were then correlated.Results:Mean magnetic susceptibility of the ischemic ROI was significantly higher than that of the contralateral ROI (0.71±11.72 ppb, -5.59±7.30 ppb; p = 0.003). Mean ADC values of the ROI in the ischemic hemisphere were significantly lower than those in the contralateral hemisphere (0.65±0.09 х 10-3mm2/s, 0.81±0.05 х 10-3mm2/s; p = 1.31 х 10-11). No significant correlation between susceptibility and ADC was found (ρ = -0.278, p = 0.106).Conclusion:Magnetic susceptibility in the ischemic tissue is measurable and is elevated when compared to the normal tissue. This may be attributed to the increased oxygen extraction fraction in the ischemic tissue. Further voxel wise analysis and larger longitudinal multi-parametric analysis correlating magnetic susceptibility with other imaging measures of tissue injury over time will help characterise the significance of lesional magnetic susceptibility changes in ischemic tissue.

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Febbraio 2023

Abstract TMP61: Lesion Growth Continues Beyond 24 Hours Following Endovascular Therapy In Some Patients With Successful Recanalization

Stroke, Volume 54, Issue Suppl_1, Page ATMP61-ATMP61, February 1, 2023. Introduction:Lesion volume on MRI or CT provides evidence of tissue response to successful recanalization by endovascular therapy. The most appropriate time to estimate “infarct” volume remains unclear. Largely for convenience, 24-48 hours has been used in clinical trials and registry datasets which may be too early to determine the final infarct volume. The objective of this study was to quantify the comparability of lesion volume using MRI measured at 24 hours versus 5 days in acute stroke patients following successful recanalization.Methods:Patients were included if they consented to the prospective GUARDS study between April 2018 through February 2022, had LVO of the anterior circulation, were treated with EVT, achieved complete revascularization defined as TICI 2b/3, and imaged with MRI at 2 hours, 24 hours, and 5 days post EVT. Two independent readers measured lesion volumes using a semi-automated validated approach on DWI at 2 and 24 hours, and FLAIR at 5 days. Statistical comparisons of lesion volumes across time points were performed. Lesion growth was defined as change in lesion volume and percent change compared to lesion volume at 2 hours.Results:Sixty-nine patients met all study criteria and were included. Median age was 66 years, 55% female, median admit NIHSS of 18, 62% with M1 LVO, and 46% treated with IV thrombolysis. Post-EVT median lesion volumes were 24mL, 35mL, and 45mL respectively for 2-hour DWI, 24-hour DWI, and 5-day FLAIR. Lesion growth based on median percent change from the 2-hour DWI was 39% [21-96] and 52% [12-145] at 24 hours and 5 days. The difference in lesion growth based on percent change from 24 hours to 5 days was not significant (p=0.17). However, there was a significant difference based on change in lesion volume, 12mL [2-25] at 24 hours and 16mL at 5 days (p=0.029). Fifty-one (74%) patients had DWI volumes at 24 hours that were ≥80% of their FLAIR volumes at 5 days. However, 18 (26%) patients continued to have lesion growth beyond 24 hours, median lesion growth of 18mL,with 11 (61%) of those having lesion growth >20mL.Conclusions:Lesion growth >20mL continues in some patients beyond 24 hours, suggesting that infarct volume at 5 days should be used as the imaging outcome when assessing tissue response to recanalization.

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Febbraio 2023

Abstract WMP49: Occult Contrast Retention Post-thrombectomy On 24-hour Follow-up CT: Associations And Impact On Imaging Analysis

Stroke, Volume 54, Issue Suppl_1, Page AWMP49-AWMP49, February 1, 2023. Introduction:CT performed 24h post-treatment is widely used to assess radiological outcomes in stroke studies. Even without visible hyperattenuation, occult angiographic contrast may persist in the brain and confound Hounsfield Unit-based imaging metrics such as Net Water Uptake (NWU), a measure of cerebral edema based on tissue hypoattenuation. We aimed to assess (1) the presence of retained contrast post-thrombectomy on 24h CT by comparing NWU measurements with and without adjustment for iodine using dual energy CT (DECT), (2) factors associated with amount of retention, and (3) its impact on the accuracy of NWU.Methods:In a prospective study of patients with anterior circulation large vessel occlusion who had post-thrombectomy follow-up DECT performed 24h post-treatment from two Comprehensive Stroke Centres (November 2021 to May 2022), NWU was calculated by interside comparison of Hounsfield Units of the infarct lesion and its mirror homolog. Retained contrast was quantified by the difference in NWU values with and without adjustment for iodine. We tested correlation between NWU and tissue swelling using relative hemispheric volume (rHV) and midline shift (MLS). Patients with visible hyperdensities from hemorrhagic transformation or visible contrast retention, and bilateral infarcts were excluded.Results:Of 125 patients analysed (median age 71 [IQR 61-80], baseline NIHSS 16 [IQR 9.75-21]), reperfusion (eTICI 2b-3) was achieved in 120 patients (96.8%). NWU measured with iodine adjustment was significantly higher than NWU measured without adjustment (17.1% vs 10.8%, p

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Febbraio 2023

Abstract TP152: Association Of 24-hour Blood Pressure Parameters Post-thrombectomy With Functional Outcomes In Anemic And Non-Anemic Patients

Stroke, Volume 54, Issue Suppl_1, Page ATP152-ATP152, February 1, 2023. Introduction:Higher blood pressure (BP) is thought to be detrimental in patients who undergo mechanical thrombectomy (MT), however, the impact of BP post-MT based on comorbidities like anemia has not been well studied. We aim to determine the association of 24-h post-MT BP parameters with clinical outcomes depending on the presenting anemia status.Methods:We conducted a retrospective chart review of patients who underwent MT at a comprehensive stroke center from 7/2014 to 12/2020. Patients were dichotomized into anemic and non-anemic groups based on the World Health Organization’s definition of anemia [hemoglobin

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Febbraio 2023